For at least the last decade, uncertainty and controversy
has swirled around human embryonic stem cell (hESC) research—how it is
performed and funded, specifically—in the United States. The American public
may have been first made aware of hESC research concerns in the mid-1990s, when
President Bill Clinton signed into law a measure that prohibited the U.S.
Department of Health and Human Services and the National Institutes of Health
(NIH) from using appropriated funds for the creation of human embryos for
research purposes, or for research in which human embryos are destroyed. Called
the Dickey-Wicker Amendment, the legislation was actually a rider attached to an
unrelated appropriations bill passed by Congress.

During the next administration, President George W. Bush passed
an executive order that restricted federal funding of research in which cell
lines were "derived without creating a human embryo for research purposes or
destroying, discarding or subjecting to harm a human embryo or fetus." Many
researchers will tell you that these actions, which cut off much-needed
government grants, effectively shut off work in this area.

It took a third presidency to change that, as in March 2009,
President Barack Obama—as one of his first acts as the nation's newly elected
leader—issued an executive order intended to reverse Bush's policy. The order
was quickly followed by new NIH guidelines for hESC research and its December
2009 approval of 13 human stem cell lines for research.

It didn't take long, however, for this order to be
challenged in several court cases—the most-watched of them taking Dickey-Wicker
to task. Sherley, et. al., v. Sebelius,
et al., a case filed in the U.S. District Court for the District of
Columbia, argued that Obama's order violates Dickey-Wicker. Last August,
federal district judge Royce Lamberth, finding enough merit in the plaintiffs'
arguments, issued a preliminary injunction that brought federal funding for
embryo-destructive research to a halt.

About a month later, the U.S. Court of
Appeals temporarily suspended the injunction while the case was still pending.

In May, the court completely reversed Lamberth's ruling,
saying it would impose a substantial hardship on stem cell researchers who have
multi-year projects already underway. The court's 2-1 decision also found that
the funding of hESC research is permissible under Dickey-Wicker, as Congress
has renewed the amendment every year with the knowledge that it funds such
research.

And as we went to press with this issue, the court pounded
its final nails into the case's coffin when it dismissed the lawsuit
altogether.

"This court, following the D.C. Circuit's reasoning and
conclusions, must find that defendants reasonably interpreted the Dickey-Wicker
Amendment to permit funding for human embryonic stem cell research because such
research is not 'research in which a human embryo or embryos are destroyed,"
Lamberth wrote in his ruling.

The jury is still out, of course, on whether the plaintiffs
will appeal this ruling.

But while grant applications are once again flowing, it's
clear that concerns about hESC research are not pacified. In fact, hESCs have
become so controversial, the field of stem cell research as a whole is shrouded
in uncertainty—at least according to the court of public opinion and some rogue
lawmakers who are under the impression that something more insidious is afoot,
like "the creation of animal-human hybrids," as one Ohio legislator has
suggested.

The question of whether the government should fund hESC
research is also being asked at the state level, as many states have enacted
laws that encourage it, restrict it or even ban it altogether. Many of those
battles are still being waged, commonly in the name of Dickey-Wicker.

With all
of this uncertainty, I can't help but wonder: Isn't it about time Congress
revisited what is essentially an afterthought on a 15-year-old appropriations
bill, clearly articulated the facts and concerns about hESC research and put
forth a specific policy on the matter?

Meanwhile, in our ongoing summer series on stem cell
research, we've got an interesting discussion with three scientists currently
working in the field—one of whom was one of the named plaintiffs in the Sherley case. We hope you will enjoy
reading their views on the subject in our editorial roundtable, which you can
see here.

We'll wrap up our series next month with a look at the stem cell
industry's major players, so until then, have a Dickey-Wicker of a summer.